FDA Clears Expanded Indication of Scalp-Cooling System

Paxman’s advanced scalp-cooling system has now been cleared by the US Food and Drug Administration (FDA) for use during treatment of patients with solid tumors. The system is now indicated to reduce the likelihood of chemotherapy-induced alopecia in cancer patients with solid tumors such as ovarian, breast, colorectal, bowel, and prostate cancers.

The expanded FDA clearance substantially increases the potential number of new patients with cancer per year that the system can be marketed to in the United States—from an estimated 250,000 breast cancer patients to over 1 million breast cancer and solid tumor cancer patients. Paxman’s 510k application for expanded use of its scalp-cooling system was submitted to the FDA in October 2017 and was supplemented in early May in response to a request for additional information and analysis.

Since its original FDA clearance in April 2017, Paxman has installed around 225 scalp-cooling systems in the United States, with a further 65 systems awaiting delivery and installation. The clearance paves the way for more people to use the system and will have a positive impact on the number of patient enrollments for systems already installed.

How It Works

The Paxman Cooling System (also known as the “cold cap”) alleviates the damage caused to hair follicles by chemotherapy. It works by reducing the temperature of the scalp by a few degrees immediately before, during, and after the administration of chemotherapy. Liquid coolant passes through the cap extracting heat from the patient's scalp, ensuring the scalp remains at an even, constant temperature to minimize hair loss.

The Paxman Scalp Cooling System has been developed by the Paxman family to reduce hair loss in patients undergoing chemotherapy. The concept behind the technology came when Sue Paxman, mother of four, experienced first-hand the trauma of chemotherapy-induced hair loss.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.

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